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Regulatory Authorities (regulatory + authority)
Kinds of Regulatory Authorities Selected AbstractsStudy on the enantiomeric ratio of the pharmaceutical substances alkannin and shikoninBIOMEDICAL CHROMATOGRAPHY, Issue 10 2004A. N. Assimopoulou Abstract The chiral pair alkannin and shikonin (A/S) are potent pharmaceutical substances with a wide spectrum of biological activity; their enantiomeric ratio does not in,uence the major biological activity studied hitherto. Nevertheless, in pharmaceutical development and approval of chiral drugs from the Health and Regulatory Authorities, full documentation of methods of analysis of enantiomeric drugs, is required in order to evaluate the enantiomeric purity of starting materials and ,nal products and to control the stability of enantiomers in pharmaceutical formulations under several experimental conditions. In the present study, the enantiomeric ratio of A/S was determined in several commercial samples of alkannin and shikonin and also the proportion of A/S derivatives in several Alkanna root samples, which are all used as active ingredients in pharmaceuticals. Light and air proved not to in,uence the enantiomeric ratio of A/S on a shikonin commercial sample, and temperature also did not alter the A/S ratio on shikonin and alkannin commercial samples. Microencapsulation of alkannin and shikonin commercial samples in ethylcellulose microspheres and also molecular inclusion of a shikonin commercial sample in , -hydroxypropyl-cyclodextrin, which are used as drug delivery systems, did not alter the A/S enantiomeric ratio. Copyright © 2004 John Wiley & Sons, Ltd. [source] The Assessment of Emergency Physicians by a Regulatory AuthorityACADEMIC EMERGENCY MEDICINE, Issue 12 2006Jocelyn M. Lockyer PhD Abstract Objectives To determine whether it is possible to develop a feasible, valid, and reliable multisource feedback program (360° evaluation) for emergency physicians. Methods Surveys with 16, 20, 30, and 31 items were developed to assess emergency physicians by 25 patients, eight coworkers, eight medical colleagues, and self, respectively, using five-point scales along with an "unable to assess" category. Items addressed key competencies related to communication skills, professionalism, collegiality, and self-management. Results Data from 187 physicians who identified themselves as emergency physicians were available. The mean number of respondents per physician was 21.6 (SD ± 3.87) (93%) for patients, 7.6 (SD ± 0.89) (96%) for coworkers, and 7.7 (SD ± 0.61) (95%) for medical colleagues, suggesting it was a feasible tool. Only the patient survey had four items with "unable to assess" percentages ,15%. The factor analysis indicated there were two factors on the patient questionnaire (communication/professionalism and patient education), two on the coworker survey (communication/collegiality and professionalism), and four on the medical colleague questionnaire (clinical performance, professionalism, self-management, and record management) that accounted for 80.0%, 62.5%, and 71.9% of the variance on the surveys, respectively. The factors were consistent with the intent of the instruments, providing empirical evidence of validity for the instruments. Reliability was established for the instruments (Cronbach's , > 0.94) and for each physician (generalizability coefficients were 0.68 for patients, 0.85 for coworkers, and 0.84 for medical colleagues). Conclusions The psychometric examination of the data suggests that the instruments developed to assess emergency physicians were feasible and provide evidence for validity and reliability. [source] Establishing Efficacy of a New Experimental Treatment in the ,Gold Standard' DesignBIOMETRICAL JOURNAL, Issue 6 2005Dieter Hauschke Abstract Provided that there are no ethical concerns, the comparison of an active drug with placebo in a randomized two-arm clinical trial provides the most convincing way to demonstrate the efficacy of a new experimental treatment. However, in a placebo-controlled clinical trial it is not sufficient to demonstrate merely a statistically significant treatment difference. Regulatory authorities strongly recommend to assess additionally whether the observed treatment difference is also of clinical relevance. The inherent issue is the necessity of the a priori definition of what constitutes a clinically relevant difference in efficacy. This problem can be solved in a three-arm study by including an active control group. We address the necessary conditions in the gold standard design which allow the claim of efficacy for the new treatment with particular focus on assay sensitivity. (© 2005 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] The Diagnosis and Prediction of Bank Failures in Zambia, 1990,98DEVELOPMENT POLICY REVIEW, Issue 3 2002Samuel Munzele Maimbo This article presents a non-econometric, yet practical approach for regulators in developing countries. With limited financial resources to determine the ,safety and soundness' of a large number of financial institutuions, regulatory authorities are appreciative of any kind of mechanism that can identify banks that are in financial difficulties. The Zambian case is interesting, in that the bank failures of 1995 and 1997/8 brought into question the ability of the central bank to diagnose the financial condition of banks. This article evaluates the Bank of Zambia's experience over the period 1990 to March 1998 and makes recommendations on how to improve diagnosis and prediction of bank failures by incorporating non-financial factors into the analysis of bank performance. [source] Comparative effects of pH and Vision® herbicide on two life stages of four anuran amphibian species,ENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 4 2004Andrea N. Edginton Abstract Vision®, a glyphosate-based herbicide containing a 15% (weight:weight) polyethoxylated tallow amine surfactant blend, and the concurrent factor of pH were tested to determine their interactive effects on early life-stage anurans. Ninety-six-hour laboratory static renewal studies, using the embryonic and larval life stages (Gosner 25) of Rana clamitans, R. pipiens, Bufo americanus, and Xenopus laevis, were performed under a central composite rotatable design. Mortality and the prevalence of malformations were modeled using generalized linear models with a profile deviance approach for obtaining confidence intervals. There was a significant (p < 0.05) interaction of pH with Vision concentration in all eight models, such that the toxicity of Vision was amplified by elevated pH. The surfactant is the major toxic component of Vision and is hypothesized, in this study, to be the source of the pH interaction. Larvae of B. americanus and R. clamitans were 1.5 to 3.8 times more sensitive than their corresponding embryos, whereas X. laevis and R. pipiens larvae were 6.8 to 8.9 times more sensitive. At pH values above 7.5, the Vision concentrations expected to kill 50% of the test larvae in 96-h (96-h lethal concentration [LC50]) were predicted to be below the expected environmental concentration (EEC) as calculated by Canadian regulatory authorities. The EEC value represents a worst-case scenario for aerial Vision application and is calculated assuming an application of the maximum label rate (2.1 kg acid equivalents [a.e.]/ha) into a pond 15 cm in depth. The EEC of 1.4 mg a.e./L (4.5 mg/L Vision) was not exceeded by 96-h LC50 values for the embryo test. The larvae of the four species were comparable in sensitivity. Field studies should be completed using the more sensitive larval life stage to test for Vision toxicity at actual environmental concentrations. [source] Statistical methods for the evaluation of health effects of prenatal mercury exposureENVIRONMETRICS, Issue 2 2003Esben Budtz-Jørgensen Abstract Environmental risk assessment based on epidemiological data puts stringent demands on the statistical procedures. First, convincing evidence has to be established that there is a risk at all. In practice this endeavor requires prudent use of the observational epidemiological information with delicate balancing between utilizing the information optimally but not over-interpreting it. If a case for an environmental risk has been made, the second challenge is to provide useful input that regulatory authorities can use to set standards. This article surveys some of these issues in the concrete case of neurobehavioral effects in Faroese children prenatally exposed to methylmercury. A selection of modern, appropriate methods has been applied in the analysis of this material that may be considered typical of environmental epidemiology today. In particular we emphasize the potential of structural equation models for improving standard multiple regression analysis of complex environmental epidemiology data. Copyright © 2003 John Wiley & Sons, Ltd. [source] Thalidomide, BSE and the single market: An historical-institutionalist approach to regulatory regimes in the European UnionEUROPEAN JOURNAL OF POLITICAL RESEARCH, Issue 1 2007SEBASTIAN KRAPOHL In the last decade, the regulatory regime for pharmaceuticals has functioned without raising public concerns. The establishment of a European agency for pharmaceuticals in the early 1990s has been evaluated positively by both producers and consumers, and there have been no large scandals so far. At the same time, the food sector was subject to a whole range of crises, of which the BSE scandal was certainly the most significant one. In reaction to this, the regulatory regime for foodstuffs was reformed by setting up the European Food Safety Agency in 2002. This article adopts an historical-institutionalist approach, and thus tries to give an explanation for the striking differences between the two regulatory regimes. Accordingly, the development of supranational regulatory regimes is distinguished by two critical junctures: a crisis of consumer confidence and the establishment of a single market. It is crucial which of these occurred first. If a crisis of consumer confidence leads to the establishment of national regulatory authorities, these authorities act as stakeholders, which could be an obstacle for harmonization, but also ensures a necessary commitment to health and consumer protection once a single market is set up. If national regulatory authorities are missing, it might be easier to set up a single market, but a regulatory deficit is more likely to occur and, in case of a crisis, the whole regulatory regime has to be established at the supranational level. [source] Dimensioning of secondary and tertiary control reserve by probabilistic methodsEUROPEAN TRANSACTIONS ON ELECTRICAL POWER, Issue 4 2009Christoph Maurer Abstract Given the rising share of intermittent generation out of renewable energy sources on the one hand and the increased regulatory efforts to lower transmission costs and tariffs on the other hand, the optimal dimensioning of necessary control reserve has gained additional importance during the last years. Grid codes like the UCTE Operation Handbook do not provide definitive and unambiguous methods for dimensioning of secondary and tertiary control reserves. This paper therefore presents a method which calculates the necessary control reserve considering all important drivers for power imbalances like power plant outages, load variations and forecast error. For dimensioning, a probabilistic criterion, the accepted probability of insufficient control reserve, is used. Probability density functions of control area imbalances are calculated using a convolution algorithm. This paper provides analyses for a stylised example system to demonstrate the capabilities of the method. In a sensitivity analysis the impact of drivers like plant failures and forecast errors of load and generation is shown. The presented method is used by transmission system operators and regulatory authorities to determine and substantiate the necessary amount of control reserve. Copyright © 2009 John Wiley & Sons, Ltd. [source] Business,Regulatory Relations: Learning to Play Regulatory Games in European Utility MarketsGOVERNANCE, Issue 3 2005DAVID COENArticle first published online: 13 JUN 200 Although regulation is on the rise in the European Union, the liberalization of the telecommunication and energy markets has not created a uniform European Regulatory model. The principle focus of this article is to examine the interaction and regulatory learning between national regulatory authorities and business in the U.K. and German utility markets to assess the degree of convergence and demonstrate how the regulatory relationship has evolved beyond that envisaged in the initial delegation of powers to the regulator. The article shows that independent regulatory authorities have moved from distant and often confrontational relationships with business to strategic working relationships driven by exchanges of information and reputation building and that regulatory learning and trust have evolved at distinct speeds in sectors and countries depending on the number of regulatory authorities in a market place, the degree to which there are concurrent powers between authorities, their discretion in the consultation process, and the length of time that regulatory authorities had existed. Consequently, significant variance is continuously seen in the business,regulator relationships in comparing the young legalist German regulatory authorities with the established independent and discretion-based regulators in the U.K. [source] From subordination to parity: an international comparison of equity securities law claims in insolvency proceedingsINTERNATIONAL INSOLVENCY REVIEW, Issue 3 2007Janis Sarra Securities law claims in insolvency proceedings raise important questions of allocation of risk and remedies. In the ordinary course of business, equity claims come last in the hierarchy of claims during insolvency. What is less clear is whether this should encompass claims arising from the violation of public statutes designed to protect equity investors. Discerning the optimal allocation of risk is a complex challenge if one is trying to maximize the simultaneous advancement of securities law and insolvency law public policy goals. From a securities law perspective, there must be confidence in meaningful remedies for capital markets violations if investors are to continue to invest. From an insolvency perspective, creditors make their pricing and credit availability choices based on certainty regarding their claims and shifting those priorities may affect the availability of credit. The critical question is the nature of the claim advanced by the securities holder and whether subordination of securities law claims gives rise to inappropriate incentives for corporate officers within the insolvency law regime. A comparative analysis reveals that the U.S. has provided a limited statutory exception to complete subordination through the fair funds provision of the Sarbanes-Oxley Act by allowing SEC claims for penalties and disgorgement to rank equally with unsecured claims even though the funds are distributed to shareholders. The U.K. and Australian schemes permit shareholders to claim directly as unsecured creditors for fraudulent acts and misrepresentation by the issuer. In contrast, Canadian law is underdeveloped in its treatment of such claims. The paper canvasses the policy options available to reconcile securities law and insolvency law claims, including a discussion of the appropriate gatekeeping role for regulatory authorities and the courts, and the need for a framework that offers fair and expeditious resolution of such claims. If the public policy goal of both securities law and insolvency law is to foster efficient and cost-effective capital markets, it seems that the systems need to be better reconciled than currently. The paper also examines the codified response to the time and resources consumed in various common law tracing claims by customers in a securities firm insolvency. Copyright © 2007 John Wiley & Sons, Ltd. [source] The first Australian nurse practitioner census: A protocol to guide standardized collection of information about an emergent professional groupINTERNATIONAL JOURNAL OF NURSING PRACTICE, Issue 5 2010Sandy Middleton RN PhD Middleton S, Gardner G, Gardner A, Della P, Gibb M, Millar L. International Journal of Nursing Practice 2010; 16: 517,524 The first Australian nurse practitioner census: A protocol to guide standardized collection of information about an emergent professional group Internationally, collection of reliable data on new and evolving health-care roles is crucial. We describe a protocol for design and administration of a national census of an emergent health-care role, namely nurse practitioners in Australia using databases held by regulatory authorities. A questionnaire was developed to obtain data on the role and scope of practice of Australian nurse practitioners. Our tool comprised five sections and included a total of 56 questions, using 28existing items from the National Nursing and Midwifery Labour Force Census and nine items recommended in the Nurse Practitioner Workforce Planning Minimum Data Set. Australian Nurse Registering Authorities (n = 6) distributed the survey on our behalf. This paper outlines our instrument and methods. The survey was administered to 238 authorized Australian nurse practitioners (85% response rate). Rigorous collection of standardized items will ensure health policy is informed by reliable and valid data. We will re-administer the survey 2 years following the first survey to measure change over time. [source] The UK air inclusive-tour industry: a reassessment of the competitive positioning of the ,independent' sectorINTERNATIONAL JOURNAL OF TOURISM RESEARCH, Issue 6 2001Nigel G. Evans Abstract This paper investigates the increasing concentration in the UK air inclusive-tour (AIT) market and the behaviour of the dominant companies (Thomson, Airtours, First Choice and Thomas Cook) operating in the sector. Arguments relating to the theoretical organisational structure of the industry are explored and regulatory investigations that have taken place are discussed. Research evidence as to the competitive position of independent tour operators in the overall UK AIT market is provided. The research indicates that a key area of difficulty for the independent sector relates to the provision of charter airline capacity although access to distribution channels and the ability to contract accommodation are viewed as further concerns. The paper concludes that regulatory authorities are faced with trying to ensure that diversity is maintained while at the same time ensuring any economies of scale derived from consolidation of the sector are passed on to consumers. In order to properly understand the true effects of industrial concentration the assembled package must be dissembled into its component parts and an increasingly a pan-European perspective is necessary. Copyright © 2001 John Wiley & Sons, Ltd. [source] Do bacteria need to be regulated?JOURNAL OF APPLIED MICROBIOLOGY, Issue 3 2006P. Silley Abstract Additives for use in animal nutrition are regulated under Regulation (EC) No. 1831/2003. The scope of this paper addresses the specific microbiological issues relevant to a microbial feed additive, containing a Bacillus spp. and uses as an example a product with the trade name, Calsporin®. Bacillus subtilis C-3102 is the active ingredient in Calsporin® and is added to animal feed to favourably affect animal production and performance (growth and feed efficiency), by modulating the gastrointestinal flora. It is not the purpose of this review to present the raw data for Calsporin® but rather to use Calsporin® as an example of the type of data required by the European regulatory authorities. At the time of preparation of this manuscript Calsporin® has yet to be reviewed by the authorities. The regulatory system under the auspices of the EFSA FEEDAP Panel is clearly attempting to move in line with development of scientific opinion and is to be applauded for such efforts. Bacteria do need to be regulated, and the regulations clearly provide adequate and appropriate protection to human health and to environmental considerations. [source] Comparison of the specificity and sensitivity of traditional methods for assessment of nephrotoxicity in the rat with metabonomic and proteomic methodologiesJOURNAL OF APPLIED TOXICOLOGY, Issue 4 2005Andy Gibbs Abstract There is currently a great deal of scientific interest and debate concerning the possible advantages that proteomic and metabonomic technologies might have over traditional biomarkers of toxicity (blood and urine chemistry, histopathology). Numerous papers have been published that make impressive claims concerning potential applications for these novel technologies, however there appears to be little hard evidence in the literature of their advantages over the traditional techniques for assessing toxicity. The aim of this review was to evaluate the relative sensitivity and specificity of proteomic and metabonomic techniques, compared with traditional techniques, for assessing xenobiotic-induced nephrotoxicity. A review of studies was performed where both one of the novel methods as well as traditional techniques were used for assessment of xenobiotic-induced nephrotoxicity. There was no consistent evidence from the literature that the novel methodologies were any more sensitive than the traditional methods for assessing nephrotoxicity. This could be due to the relatively small number of studies available for review (n = 13), the fact that generally these studies were not aimed at determining relative sensitivity or specificity and may not be the case with other target organs, such as the liver. However, it was clear that the novel methodologies were able to discriminate between the effects caused by different toxicants. There was evidence both that this discrimination was on the basis of different mechanisms of toxicity and on the basis of different locations of nephrotoxic lesion. A great deal of validation work is necessary before these techniques could gain full acceptance by regulatory authorities, and it is unclear whether their use in anything other than non-regulatory, mechanistic studies is likely to become widespread. Copyright © 2005 John Wiley & Sons, Ltd. [source] Modelling the spatial configuration of refuges for a sustainable control of pests: a case study of Bt cottonJOURNAL OF EVOLUTIONARY BIOLOGY, Issue 3 2003C. Vacher Abstract The ,high-dose-refuge' (HDR) strategy is widely recommended by the biotechnology industry and regulatory authorities to delay pest adaptation to transgenic crops that produce Bacillus thuringiensis (Bt) toxins. This involves cultivating nontoxic plants (refuges) in close proximity to crops producing a high dose of Bt toxin. The principal cost associated with this strategy is due to yield losses suffered by farmers growing unprotected, refuge plants. Using a population genetic model of selection in a spatially heterogeneous environment, we show the existence of an optimal spatial configuration of refuges that could prevent the evolution of resistance whilst reducing the use of costly refuges. In particular, the sustainable control of pests is achievable with the use of more aggregated distributions of nontransgenic plants and transgenic plants producing lower doses of toxin. The HDR strategy is thus suboptimal within the context of sustainable agricultural development. [source] Ototoxic eardrops and tympanic membrane perforations: Time for a change?JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 8 2005Harvey Coates Abstract: Until recently the only available antibiotic eardrops for treatment of the discharging middle ear and mastoid cavity have been potentially ototoxic. With the advent of non-ototoxic fluoroquinolone eardrops, consensus panels in the USA, Canada and the UK have advocated the preferential use of these agents in the open middle ear. However, in Australia, no fluoroquinolone topical agent is approved for use with tympanic membrane perforations, and when used as an ,off label' eardrop, none is on the Pharmaceutical Benefits Scheme. This creates an ethical dilemma, particularly with best practice management of chronic suppurative otitis media in indigenous children. Despite concerns regarding resistance issues with ototopical use of systemic antibiotics, bacterial resistance has not been documented in major studies. For equity and ethical reasons, Australian regulatory authorities should consider approving a sterile non-ototoxic eardrop for use in the open middle ear. [source] Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patientsJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2005S. SCHULMAN Summary., A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities. [source] Exploration of developmental approaches to companion animal antimicrobials: providing for the unmet therapeutic needs of dogs and catsJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2010AAVPT, White Paper Committee Committee members:, Workshop AAVPT Workshop White Paper Committee. Exploration of developmental approaches to companion animal antimicrobials: providing for the unmet therapeutic needs of dogs and cats. J. vet. Pharmacol. Therap.33, 196,201. The American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) and the United States Pharmacopeia (USP) co-sponsored a workshop to explore approaches for developing companion animal antimicrobials. This workshop was developed in response to the shortage of antimicrobials labeled for dogs and cats, as there is a shortage of approved antimicrobials for the range of infectious diseases commonly treated in small animal practice. The objective of the workshop was to identify alternative approaches to data development to support new indications consistent with the unmet therapeutic needs of dogs and cats. The indications for currently approved antimicrobials do not reflect the broader range of infectious diseases that are commonly diagnosed and treated by the veterinarian. Therefore, the labels for these approved antimicrobials provide limited information to the veterinarian for appropriate therapeutic decision-making beyond the few indications listed. Industry, veterinary practice, and regulatory challenges to the development of new antimicrobial indications were discussed. The workshop resulted in short- and long-term recommendations. Short-term recommendations focus on the use of additional data considerations for product labeling. Long-term recommendations center on legislative or regulatory legal initiatives. The workshop recommendations will need collaboration from industry, academia, and regulatory authorities and a legal shift in the drug approval and availability processes. [source] Risk of first-generation H1 -antihistamines: a GA2LEN position paperALLERGY, Issue 4 2010M. K. Church To cite this article: Church MK, Maurer M, Simons FER, Bindslev-Jensen C, van Cauwenberge P, Bousquet J, Holgate ST, Zuberbier T. Risk of first-generation H1 -antihistamines: a GA2LEN position paper. Allergy 2010; 65: 459,466. Abstract Background: First-generation H1 -antihistamines obtained without prescription are the most frequent form of self-medication for allergic diseases, coughs and colds and insomnia even though they have potentially dangerous unwanted effects which are not recognized by the general public. Aims:, To increase consumer protection by bringing to the attention of regulatory authorities, physicians and the general public the potential dangers of the indiscriminate use first-generation H1 -antihistamines purchased over-the counter in the absence of appropriate medical supervision. Methods:, A GA2LEN (Global Allergy and Asthma European Network) task force assessed the unwanted side-effects and potential dangers of first-generation H1-antihistamines by reviewing the literature (Medline and Embase) and performing a media audit of US coverage from 1996 to 2008 of accidents and fatal adverse events in which these drugs were implicated. Results:, First-generation H1 -antihistamines, all of which are sedating, are generally regarded as safe by laypersons and healthcare professionals because of their long-standing use. However, they reduce rapid eye movement (REM)-sleep, impair learning and reduce work efficiency. They are implicated in civil aviation, motor vehicle and boating accidents, deaths as a result of accidental or intentional overdosing in infants and young children and suicide in teenagers and adults. Some exhibit cardiotoxicity in overdose. Conclusions:, This review raises the issue of better consumer protection by recommending that older first-generation H1 -antihistamines should no longer be available over-the-counter as prescription- free drugs for self-medication of allergic and other diseases now that newer second- generation nonsedating H1 -antihistamines with superior risk/benefit ratios are widely available at competitive prices. [source] When (not) to indulge in ,puffery': the role of consumer expectations and brand goodwill in determining advertised and actual product qualityMANAGERIAL AND DECISION ECONOMICS, Issue 6 2000Praveen K. Kopalle We analyze why some firms advertise product quality at a level different from the actual quality of a product. By considering the interacting effects of product quality and advertising, we develop a dynamic model of consumer expectations about product quality and the development of brand goodwill to determine the optimal values for the decision variables. The model parameters are determined based on prior literature and we use numerical techniques to arrive at the solution. We then derive conditions under which a firm will find it optimal to overstate or understate product quality. The results suggest that quality may be overstated in markets characterized by high price sensitivity, low quality sensitivity, low brand loyalty, and high source credibility, suggesting the need for vigilance on the part of consumers, upper level managers and regulatory authorities in such market conditions. This is important because current regulatory resources are insufficient to reduce deceptive advertising practices (Davis JJ. 1994. Ethics in advertising decision-making: implications for reducing the incidence of deceptive advertising. Journal of Consumer Affairs28: 380,402). Further, the law of deceptive advertising prohibits some advertising claims on the ground that they are likely to harm consumers or competitors (Preston IL, Richards JI. 1993. A role for consumer belief in FTC and Lanham Act deceptive advertising cases. American Business Law Journal31: 1,29). Also, Nagler (1993. Rather bait than switch: deceptive advertising with bounded consumer rationality. Journal of Public Economics51: 359,378) shows that deceptive advertising causes a net social welfare loss and a public policy effectively preventing deception will improve social welfare. Copyright © 2000 John Wiley & Sons, Ltd. [source] Standardization of allergen products: 1.ALLERGY, Issue 7 2009Detailed characterization of GMP-produced recombinant Bet v 1.0101 as biological reference preparation Background:, Standardization of allergen extracts requires the availability of well-characterized recombinant allergens, which can be used as reference standards provided by the European regulatory authorities. The objective of this study was the detailed physicochemical and immunological characterization of rBet v 1.0101, which shall be used in a ring trial within the framework of the Biological Standardization Programme BSP090 of the European Directorate for Quality of Medicines and Healthcare. Methods:, Recombinant Bet v 1.0101 Y0487 was produced under good manufacturing practice conditions and analysed by an array of physicochemical and immunological methods for identity, quantity, homogeneity, folding and denaturation, aggregation state and stability in solution, as well as biological activity. Results:, Batch Y0487 was shown to contain monomeric and well-folded protein being identical with rBet v 1.0101, as determined by mass spectrometry. SDS-PAGE, isoelectric focusing, deamidation analysis and size-exclusion chromatography with light scattering revealed sample homogeneity of >99.9%. Upon storage at +4°C batch Y0487 retained the monomeric state up to 3 months. Protein quantification determined by amino acid analysis was found coinciding with half-maximal inhibition of serum IgE in ELISA. Biological activity of batch Y0487 was shown to be comparable to natural Bet v 1 by IgG and IgE immunoblotting, as well as basophil and T-cell activation. Conclusion:, Recombinant Bet v 1.0101 Y0487 was characterized extensively by physicochemical and immunological methods. It was shown highly stable, monomeric and immunologically equivalent to its natural counterpart. Thus, it represents an appropriate candidate reference standard for Bet v 1. [source] Thresholds for food allergens and their value to different stakeholdersALLERGY, Issue 5 2008R. W. R Crevel Thresholds constitute a critical piece of information in assessing the risk from allergenic foods at both the individual and population levels. Knowledge of the minimum dose that can elicit a reaction is of great interest to all food allergy stakeholders. For allergic individuals and health professionals, individual threshold data can inform allergy management. Population thresholds can help both the food industry and regulatory authorities assess the public health risk and design appropriate food safety objectives to guide risk management. Considerable experience has been gained with the double-blind placebo-controlled food challenge (DBPCFC), but only recently has the technique been adapted to provide data on thresholds. Available data thus vary greatly in quality, with relatively few studies providing the best quality individual data, using the low-dose DBPCFC. Such high quality individual data also form the foundation for population thresholds, but these also require, in addition to an adequate sample size, a good characterization of the tested population in relation to the whole allergic population. Determination of thresholds at both an individual level and at a population level is influenced by many factors. This review describes a low-dose challenge protocol developed as part of the European Community-funded Integrated Project Europrevall, and strongly recommends its wider use so that data are generated that can readily increase the power of existing studies. [source] Development of EuroFIR-BASIS , a composition and biological effects database for plant-based bioactive compoundsNUTRITION BULLETIN, Issue 1 2008L. Black Summary Bioactive compounds, such as those derived from plant foods, are of growing interest to the scientific community and food industry because of their putative health-promoting properties. Increasing evidence reports beneficial effects of bioactive compounds, particularly against cancers, cardiovascular diseases and diabetes. EuroFIR-BASIS (BioActive Substances in Food Information System) is a unique online database that collates international research on the composition and biological effects of plant-based bioactive compounds into a single, comprehensive reference resource. EuroFIR-BASIS covers multiple compound classes and 330 major European food plants with data sourced from quality-assessed, peer-reviewed literature. The database is internet-deployed to ensure widespread accessibility and facilitates searches against a number of different variables. EuroFIR-BASIS is intended for use by a wide audience, including scientists, researchers, epidemiologists, food regulatory authorities and product developers in the food industry. The database has been designed to accommodate continual expansion as research develops to ensure that it remains a current and useable resource. [source] The Welfare Effects of the National Cooperative Research Act (NCRA) of 1984 and the National Cooperative Production Amendments (NCPA) of 1993AMERICAN JOURNAL OF ECONOMICS AND SOCIOLOGY, Issue 5 2007Yi Liu Cooperative R&D and production joint ventures may enable firms to achieve significant cost efficiencies. However, they can also be a means of controlling industry output and raising product prices. A review of the literature on the welfare implications of allowing rival firms to cooperate in the R&D and production stages indicates that the issue is controversial from a theoretical perspective. There is need to examine the motivations of R&D and production joint ventures in order to assess the welfare implications of the National Cooperative Research Act (NCRA) of 1984 and National Cooperative Production Amendments (NCPA) of 1993, which relaxed the antitrust treatment of R&D and production joint ventures. Using samples of 127 cooperative R&D joint ventures and 342 cooperative production joint ventures announced by U.S. domestic firms during 1979,1999, this article finds that these endeavors do not meet the criteria for collusive behavior specified by the market power doctrine. We interpret these findings as suggesting that cooperative R&D and production joint ventures are motivated by cost efficiencies and are, therefore, welfare enhancing. Our results pose some challenges to the doctrine that antitrust actions by regulatory authorities are always welfare improving. [source] Consideration of regional difference in design and analysis of multi-regional trials,,PHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 3 2010H. M. James Hung Abstract Clinical trial strategy, particularly in developing pharmaceutical products, has recently expanded to a global level in the sense that multiple geographical regions participate in the trial simultaneously under the same study protocol. The possible benefits of this strategy are obvious, at least from the cost and efficiency considerations. The challenges with this strategy are many, ranging from trial or data quality assurance to statistical methods for design and analysis of such trials. In many regulatory submissions, the presence of regional differences in the estimated treatment effect, whether they are different only in magnitude or in direction, often presents great difficulty in interpretation of the global trial results, particularly for the acceptability by the local regulatory authorities. This article presents a number of useful statistical analysis tools for exploration of regional differences and a method that may be worth consideration in designing a multi-regional clinical trial. Published in 2010 by John Wiley & Sons, Ltd. [source] An optimal adaptive design to address local regulations in global clinical trials,PHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 3 2010Xiaolong Luo Abstract After multi-regional clinical trials (MRCTs) have demonstrated overall significant effects, evaluation for a region-specific effect is often important. Recent guidance (see, e.g. 1) from regulatory authorities regarding evaluation for possible country-specific effects has led to research on statistical designs that incorporate such evaluations in MRCTs. These statistical designs are intended to use the MRCTs to address the requirements for global registration of a medicinal product. Adding a regional requirement could change the probability for declaring positive effect for the region when there is indeed no treatment difference as well as when there is in fact a true difference within the region. In this paper, we first quantify those probability structures based on the guidance issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan. An adaptive design is proposed to consider those probabilities and to optimize the efficiency for regional objectives. This two-stage approach incorporates comprehensive global objectives into an integrated study design and may mitigate the need for a separate local bridging study. A procedure is used to optimize region-specific enrollment based on an objective function. The overall sample size requirement is assessed. We will use simulation analyses to illustrate the performance of the proposed study design. Copyright © 2010 John Wiley & Sons, Ltd. [source] Early communication of drug safety concerns: a feasibility study on enhancing interaction between the pharmaceutical industry and regulatorsPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2010Elizabeth Swain BPharm, MRPharmS Abstract Purpose The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making. Methods Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities. Results During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation. Conclusions The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities. Copyright © 2009 John Wiley & Sons, Ltd. This article was published online on December 27, 2009. An error was subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected (08/01/10). [source] A quantitative approach to benefit-risk assessment of medicines , part 1: the development of a new model using multi-criteria decision analysis,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue S1 2007Filip Mussen PhD Abstract Purpose One of the most important uses of benefit-risk assessment pertains to approval of new medicines by regulatory authorities and the subsequent review of these products during their life-cycle when new safety and/or efficacy data becomes available. At present, there exist no validated, well-accepted models for benefit-risk assessment that have the appropriate degree of sophistication, and as a consequence no models are widely used by regulatory authorities or industry. The aim of the study was therefore to develop a new model for benefit-risk assessment of medicines using multi-criteria decision analysis (MCDA). Methods The MCDA methodology was used for a systematic approach to assess the benefit risk ratio of medicines. The reasons for adopting this approach were (1) taking multiple benefit and risk criteria into account, (2) making a judgement on the evidence and potential uncertainty because of the incompleteness of evidence, and (3) making trade-offs of the benefits against risks. Results It was demonstrated through a seven-step approach how MCDA is used to construct the model. Ten benefit and ten risk criteria were identified to form a value tree. Then fixed scales were established for all criteria and options on the criteria were scored. Weights were assigned for each criteria using swing-weighting. Finally sensitivity analysis was carried. Conclusions This novel approach based on MCDA has the potential for being applied as a new tool for judging and deciding on the benefits and risks, thereby helping regulators and industry in the development and approval of new medicines and their adequate use. Copyright © 2007 John Wiley & Sons, Ltd. [source] Case for and against specificity of depression in Alzheimer's diseasePSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 4 2010Christian Even MD Aims:, The aims of this study were to assess the epidemiological, phenomenological, and pathophysiological evidence that suggests the specificity of depression associated with Alzheimer's disease (AD). Methods:, We reviewed the English-language literature. Results:, Depression occurs significantly more often in patients with AD than in the general elderly population. While development of depression in response to the disability and emotional stress of AD may be a contributory factor in some patients, several studies showed that depression was not, or was only seldom, related to self-awareness of AD and these studies could not explain the high prevalence figures. To overcome the overlapping phenomenology of the two diseases, specific diagnostic criteria have been developed for depression in this context. Mixed findings have come from neuropathological and neuroimaging studies, with some evidence linking the underlying neural substrate of AD and depression, suggesting an overlapping cause of primary depression and depression comorbid with AD. Few randomized controlled trials for depression associated with AD have been conducted, with rather poor results for the use of antidepressants. Conclusions:, Currently, depression associated with AD is not considered a separate disorder by regulatory authorities and is unlikely to be considered as such in the near future. Several obstacles remain to support such a specific position, including the heterogenous nature of depression in general and within AD itself, the lack of a distinct set of symptoms, and limited treatment. [source] Do markets enhance convergence on international standards?REGULATION & GOVERNANCE, Issue 4 2007The case of financial regulation Abstract Why do countries that did not participate in the establishment of international standards converge on them in the absence of external coercion? The market-based perspective asserts that market forces enhance cross-national convergence on international standards. This paper challenges the market-based perspective, focusing on compliance with the 1988 Basel Capital Accord in South Korea and Taiwan. First, it argues that adoption of the Basel Capital Accord by these countries was mainly driven by their regulatory authorities' concern about the potential risk of foreign market closure to noncompliant banks. Second, it demonstrates that enforcement by the two countries' regulatory authorities was crucial in ensuring compliance. These findings suggest that national regulatory authorities are still key actors in voluntary convergence on international standards. [source] | |||||||||||||||||||||||||